The doll had a tracheotomy tube—just like Kremer’s 3-year-old brother, Dusty—and she and her family were learning how to do this important task so that Dusty, who had been diagnosed with what was believed to be cerebral palsy, could be discharged from the hospital.
“One of the things I had to do was coil a tube around my finger so that it was the right geometry to go down the throat, and I remember thinking, ‘Why doesn’t it come precurled so it’s ready to go in the tracheotomy tube?’ ” says Kremer, shown above presenting research at the 2016 Kilmer Conference. “That’s my first memory of thinking about how to solve a problem, even though I didn’t know it was a problem back then.”
If you have a medical procedure, I’ve likely played a role in making sure whatever device touches you during surgery is sterile.
Most recently, Kremer led the team that created a digital app that uses big data sets to help Johnson & Johnson engineers know at the start of the design process whether a device can be fully processed—including cleaning, inspection and sterilization—or if there are issues that can prevent the device from being fully cleaned or inhibit effective terminal sterilization, like occluded surfaces or long, narrow lumens. “If we know this up front, we don’t get into a situation where we’ve designed something that can’t or is difficult to be cleaned or sterilized,” she says. “Nor would we have to write complex instructions for cleaning and sterilization that healthcare workers may have a hard time following.”
The ultimate goal is to use this data to better understand what types of medical devices lend themselves to automated cleaning and sterilization processes—essentially, self-cleaning tools that require minimum human interaction in the cleaning and disinfecting process, eliminating the chance of human error. “This new app, which is currently being tested by Johnson & Johnson engineers, is setting the foundation for the future where robots may clean and sterilize devices directly after surgery,” says Kremer. “It provides the foundational science and digital platform that’ll help us get there.”
To learn more about the app, other microbiological assurance innovations Kremer has worked on and what drives her passion for her work, read on.
Q:
What inspired you to go into the medical field?
A:
When I was growing up in Heber City, Utah, we spent a lot of time in the hospital because my younger brother, Dusty, was misdiagnosed with cerebral palsy at the age of 2.
He actually had a brain stem problem where his vertebrae didn’t fully fuse, and it slowly caused scar tissue to form around his brain stem and crush it, which impacted all of his involuntary functions. Doctors told us he would only live to be 5 years old, and I’m pleased to say he turned 40 this year.
While at the hospital, I was that sibling who was there, watching what the physicians were doing. It gave me an appreciation for medicine, but not in a way that made me want to be a practicing physician or nurse. I wanted to be a scientist helping to drive what happens behind the scenes.
The medical interventions I watched Dusty go through taught me about advocacy for those who can’t advocate for themselves. It also showed me how important it is to have the proper hygiene, since my brother is at risk for so many things because his immune system is suppressed.
Q:
What exactly is microbiological quality and sterility assurance?
A:
If you have a medical procedure, your healthcare provider may use devices that come sterile and ready for use. But there are others that are intended to be cleaned, disinfected and/or sterilized at the facility where you’re being treated—an approach called device processing. These devices are made of materials that are meant to be used again and again. Think of them as your plates and utensils at home. You use them and then clean and disinfect them by washing them manually or with an automated system like the dishwasher.
The same things happen within a healthcare environment. Certain types of devices may have complex features or they’re very expensive, and they don’t lend themselves to single use. A particular focus of my career is on designing how to clean, disinfect and sterilize those devices—and I’ve either validated the instructions healthcare workers must follow to make sure the devices are actually sterile or worked with the companies creating those instructions.
How the device is to be used on the patient dictates what steps are required for processing. All devices must be cleaned, but the level of cleanliness is different based on the contact the device has with the patient. For example, a blood pressure cuff requires a different level of cleanliness than an instrument used during orthopedic surgery. Disinfection or sterilization is also decided based on patient risk.
Q:
What’s the difference between sterilization and disinfection?
A:
Sterilization is required for devices like surgical tools that will come in contact with internal parts of the body. During the sterilization process all microorganisms are killed. For reusable medical devices this commonly means exposing them to very high temperatures (>132°C) with moist heat (i.e., steam) or vaporized hydrogen peroxide.
Disinfection, on the other hand, is a method of microbial reduction that has different levels. Devices like MRI machines, which only touch the outside of the body, require a lower level of what’s known as microbial inactivation—the process of destroying or deactivating microorganisms, such as bacteria and viruses, to prevent them from causing illness. Devices like endoscopes that enter the body, but only contact mucus membranes, require a much higher level.
The bottom line: If we don’t design the device optimally and provide the appropriate device-processing steps for the patient, infections could be an unfortunate result.
Q:
Name a science or health breakthrough you hope to see in your lifetime.
A:
I’m hoping we get to a point where we can start sorting devices into those that have the ability to be cleaned automatically and those that still need manual intervention. I don’t know that we’ll get to a point where all devices will be able to be mechanically cleaned without any human manipulation. But my hope is that the processing of the majority of devices will be fully automated.
Q:
What’s the biggest misconception people have about microbiologists like yourself that you’d love the chance to call out?
A:
When everything is going well, you don’t know I exist. The COVID-19 pandemic reminded a lot of people that microbiology is very important, and the ability to detect as well as control contamination becomes so critical when it comes to patient safety. We are sometimes the unsung heroes when it comes to that type of work, because most of the time, we’re preventing problems before you ever see them occur.
Q:
What’s your proudest professional achievement so far?
A:
Getting my Ph.D.—something that happened thanks to Johnson & Johnson contributing to the collective data for this application and also allowing this data to be shared and used externally. I was able to use the data to support my Ph.D. thesis.
It was a win-win-win. In parallel with the Ph.D. work, we built an app that has the potential to change the way we design and validate medical devices. Johnson & Johnson then allowed that data to be shared externally in a way that can help the broader community categorize reusable medical devices for cleaning.
Q:
Describe your best day on the job.
A:
Every day. I know that sounds funny, but when I joined Johnson & Johnson seven years ago, what I noticed happening is that I really hated Friday and I really hated Sunday. I hated Friday because I had to stop working. And then Sunday, I was sad because I was ending my weekend.
Q:
Any passions outside of work?
A:
I have two boys, 14 and 9, so a lot of my weekends and evenings revolve around being a parent. My husband is amazing and fully supportive, and he stays at home with our kids to be able to support my career and what I’m doing.
During the week, we’re all in this groove of working and getting things done. And then on the weekends, we spend a lot of time playing. We like outdoor activities, like mountain biking, kayaking and hiking.
Q:
Who in your field inspires you?
A:
These days, I’m inspired by biographies of scientists who struggled for most of their lives without recognition. It’s not as much about the people as much as it is about their struggles.
As we’re starting to talk about a new cleaning classification system and the process of adoption, I’m thinking a lot about Earle Spaulding, who created the microbial reduction classification that’s used widely now. But it took him 40 years to get the industry to accept it! This journey of generating science and then having people accept it is one that I’m on right now. It can take some effort to stay patient and positive.
